EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2008 (No. 5)
Potassium chloride and Potassium nitrate
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2008 (No. 5) (‘the Listing Notice’) is a notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (‘the Act’).
The Listing Notice permits the use of potassium chloride or potassium nitrate as an active ingredient in listed medicines subject to certain conditions.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (‘TGA’) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (‘ARTG’) before being supplied in, imported into, manufactured in, or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In Australia, products that contain low risk ingredients are referred to as listed medicines. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines. As they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
In order to facilitate the timely approval of new listable goods, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a notice that has the effect of permitting the use of specified therapeutic goods in listed medicines subject to any specified conditions.
Schedule 4 of the Therapeutic Goods Regulations 1990 (‘the Regulations’) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. Part 5 of Schedule 4 is for substances other than vitamins, minerals and plant material that are for use in listed medicines. Division 1 of Part 5 is for substances not mentioned in Division 2 or 3 that may be ingredients of preparations.
Pursuant to subsection 9A(6) of the Act, when Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of the Listing Notice, the Listing Notice ceases to have effect.
On 3 April 2008, the Medicines Evaluation Committee (‘MEC’) meeting was asked to advise whether potassium chloride and potassium nitrate are suitable as ingredients in low risk listed medicines. MEC is a statutory committee established under subregulation 42ZZB(1) of the Regulations which gives scientific and policy advice to the Minister for Health and Ageing and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.
a) Potassium chloride
The ingredient potassium chloride is included as an active ingredient at a concentration of 3.75% in many registered toothpastes to treat dental hypersensitivity. The chemical characteristics of potassium chloride are well known and potassium chloride was not scheduled by the National Drugs and Poisons Schedule Committee (‘NDPSC’) until 2005.
Potassium chloride for oral use is now included in Schedule 4 of the Standard for Uniform Scheduling of Drugs and Poisons (‘SUSDP’). Although, there is no definition of ‘oral’ in the SUSDP, it is generally accepted that oral means for ingestion and toothpastes are considered to be for dental/topical use on teeth, thus the risk of ingesting a significant amount of potassium from toothpaste containing potassium chloride is low.
MEC has recommended that potassium chloride is suitable for use as an active ingredient in listed medicines with the following conditions:
- the route of administration is restricted to dental use only, being use on the teeth; and
- the total potassium content in the product must not exceed an amount equivalent to a 3.75% concentration of potassium chloride, which will restrict the potassium ion in the product to 20 g/kg.
b) Potassium nitrate
The ingredient potassium nitrate at a concentration of 5% is included as an active ingredient in many registered toothpastes to treat dental hypersensitivity. The chemical characteristics of potassium nitrate are well known and it is not scheduled by the NDPSC.
MEC has recommended that potassium nitrate is suitable for use as an active ingredient in listed medicines with the following conditions:
- the route of administration is restricted to dental use only, being use on the teeth; and
- the total potassium content in the product must not exceed an amount equivalent to a 5% concentration of potassium nitrate, which will restrict the potassium ion in the product to 20 g/kg.
Potassium chloride and potassium nitrate are the subject of monographs in the British Pharmacopoeia 2008 (‘BP’). The BP and Therapeutic Goods Orders (‘TGOs’) are the official standards for regulatory purposes in Australia. Where a substance is covered by a monograph in the BP then this is the minimum standard that must be applied in its entirety, otherwise a justification is required.
CONSULTATION
Although no consultation is required in relation to the Listing Notice as the regulation change is minor and machinery in nature, the TGA has consulted MEC during the approval process for potassium chloride and potassium nitrate.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement (‘RIS’) is necessary in relation to the Listing Notice as the listing of the ingredients potassium chloride and potassium nitrate is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.